Hospital Management and 1-year Outcome of Patients Aged 70 Years and Older With Severe COVID-19 (NCT05184166) | Clinical Trial Compass
CompletedNot Applicable
Hospital Management and 1-year Outcome of Patients Aged 70 Years and Older With Severe COVID-19
France361 participantsStarted 2022-03-24
Plain-language summary
SARS-COV-2 infection can progress to acute respiratory distress syndrome and require hospitalization in the ICU in 5-20% of affected patients. Age is a major risk factor for developing a severe form and for death. ARDS related to SARS-COV-2 has specific features, including the need for long mechanical ventilation and length of stay and the use of corticosteroid therapy. These specificities are responsible for significant morbidity (neuromyopathy, delirium, post-resuscitation syndrome) and mortality during the first wave (46% at 3 months for the population of patients aged 70 years and over). To investigator's knowledge, no study has evaluated the prognosis in the ICU and the long-term functional outcome of elderly people admitted for a severe or critical form of COVID-19 since the major changes in management (dexamethasone, screening for thrombo-embolic complications, use of high-flow oxygen therapy as first-line treatment...).
Investigator therefore propose a 1-year follow-up of a cohort of patients aged 70 and over hospitalised in a conventional service or in intensive care for a severe or critical form of COVID-19. The objectives are to describe the prognosis and functional outcome of hospitalized elderly patients with severe COVID-19.
Who can participate
Age range
70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age ≥ 70 years on admission to hospital
* diagnosis of SARS-CoV-2 infection defined by a positive RT-PCR test
* medical or critical care hospitalisation between 1 July 2020 and 31 August 2021
* who experienced severe hypoxaemic acute respiratory failure defined as at least 4L/min of oxygen during hospitalisation
Exclusion Criteria:
* Oxygen therapy \< 4L/min during hospitalisation
* Mc Cabe score 3 (chronic disease fatal at 1 year such as stage IV heart failure, ventilated respiratory failure, metastatic cancer, Child C cirrhosis)
* dementia or cognitive disorders before hospitalisation reported in the medical record
* patient GIR 1 to 4 before hospitalisation reported in the medical file or deduced from the description of the lifestyle
* patient with an ADL score \< 4 before hospitalisation reported in the medical record or deduced from the description of lifestyle
* patient living in EHPAD before hospitalisation
* non-French speaking patient
* patient under guardianship or curatorship
* refusal to participate in the study for patients surviving 1 year or refusal by a family member or trusted person
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mortality of patients aged 70 years and over 1 year after diagnosis of SAR-COV2 infection